ECRI, Plymouth Meeting, PA, United States.
Division of General Internal Medicine, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.
JMIR Mhealth Uhealth. 2022 May 2;10(5):e33261. doi: 10.2196/33261.
In the era of digital health information technology, there has been a proliferation of devices that collect patient-generated health data (PGHD), including consumer blood pressure (BP) monitors. Despite their widespread use, it remains unclear whether such devices can improve health outcomes.
We performed a systematic review of the literature on consumer BP monitors that collect PGHD for managing hypertension to summarize their clinical impact on health and surrogate outcomes. We focused particularly on studies designed to measure the specific effect of using a BP monitor independent of cointerventions. We have also summarized the process and consumer experience outcomes.
An information specialist searched PubMed, MEDLINE, and Embase for controlled studies on consumer BP monitors published up to May 12, 2020. We assessed the risk of bias using an adapted 9-item appraisal tool and performed a narrative synthesis of the results.
We identified 41 different types of BP monitors used in 49 studies included for review. Device engineers judged that 38 (92%) of those devices were similar to the currently available consumer BP monitors. The median sample size was 222 (IQR 101-416) participants, and the median length of follow-up was 6 (IQR 3-12) months. Of the included studies, 18 (36%) were designed to isolate the clinical effects of BP monitors; 6 of the 18 (33%) studies evaluated health outcomes (eg, mortality, hospitalizations, and quality of life), and data on those outcomes were unclear. The lack of clarity was due to low event rates, short follow-up duration, and risk of bias. All 18 studies that isolated the effect of BP monitors measured both systolic and diastolic BP and generally demonstrated a decrease of 2 to 4 mm Hg in systolic BP and 1 to 3 mm Hg in diastolic BP compared with non-BP monitor groups. Adherence to using consumer BP monitors ranged from 38% to 89%, and ease of use and satisfaction ratings were generally high. Adverse events were infrequent, but there were a few technical problems with devices (eg, incorrect device alerts).
Overall, BP monitors offer small benefits in terms of BP reduction; however, the health impact of these devices continues to remain unclear. Future studies are needed to examine the effectiveness of BP monitors that transmit data to health care providers. Additional data from implementation studies may help determine which components are critical for sustained BP improvement, which in turn may improve prescription decisions by clinicians and coverage decisions by policy makers.
在数字健康信息技术时代，出现了大量可收集患者生成健康数据（PGHD）的设备，包括消费者血压（BP）监测仪。尽管这些设备已广泛应用，但尚不清楚它们是否能改善健康结果。
我们对收集 PGHD 以管理高血压的消费者 BP 监测仪的文献进行了系统综述，以总结其对健康和替代结局的临床影响。我们特别关注旨在单独测量使用 BP 监测仪的具体效果的研究，同时还总结了使用过程和消费者体验的结果。
信息专家检索了截至 2020 年 5 月 12 日发表的关于消费者 BP 监测仪的对照研究，检索数据库包括 PubMed、MEDLINE 和 Embase。我们使用改良的 9 项评估工具评估偏倚风险，并对结果进行叙述性综合。
我们共确定了 49 项研究中使用的 41 种不同类型的 BP 监测仪。设备工程师判断其中 38 种（92%）设备与目前可用的消费者 BP 监测仪相似。纳入研究的样本量中位数为 222 人（IQR 101-416），随访时间中位数为 6 个月（IQR 3-12）。在纳入的研究中，18 项（36%）旨在分离 BP 监测仪的临床效果；其中 6 项（33%）研究评估了健康结局（如死亡率、住院和生活质量），但这些结局的数据不明确。不明确的原因是事件发生率低、随访时间短以及存在偏倚风险。所有 18 项单独评估 BP 监测仪效果的研究均同时测量了收缩压和舒张压，与非 BP 监测仪组相比，收缩压平均降低 2-4mmHg，舒张压平均降低 1-3mmHg。消费者 BP 监测仪的依从性为 38%-89%，使用便利性和满意度评分普遍较高。不良事件少见，但设备存在一些技术问题（如设备报警错误）。
总体而言，BP 监测仪在降低血压方面具有较小的益处，但这些设备对健康的影响仍不清楚。需要进一步的研究来评估向医疗保健提供者传输数据的 BP 监测仪的有效性。来自实施研究的额外数据可能有助于确定哪些组件对持续改善血压至关重要，这反过来又可能改善临床医生的处方决策和政策制定者的覆盖决策。
